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Medical Forum / Diseases and Disorders / Arthritis / December 2004

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New Prefilled Enbrel Experience

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Ted - 17 Dec 2004 05:05 GMT
Hello all....

I have been on Enbrel (for psoriatic arthritis) since April. While it
hasn't been the miracle Amgen's advertising agency portrays, it has been
quite helpful. After some rather persistent pushing from Amgen (two
e-mails, a snail mail, and a phone call) I asked my doctor for a
prescription for the new prefilled syringe version.

I took my first injection of the new prefilled syringe version tonight.
The first thing I noticed was that the needle did not go into my skin as
easily or smoothly as with the old version. Then, as I pushed the
plunger down, I felt stinging as the fluid went in. Nothing horrible,
just very unexpected. In the seven months I've been taking the old
version I never felt much of anything during the injection.

I called the Amgen support number to talk to a nurse about this. Maybe I
had a bad lot? She seemed rather evasive when I mentioned the unexpected
stinging, suggesting only that I talk to my doctor about it. When I
asked whether she was aware of other people reporting it, her reply was
that "the HIPAA privacy law" prevented any disclosure of what other
people might have reported. When I said that I didn't understand what
HIPAA had to do with my question (it controls the handling and
disclosure of *individual* medical records), she just repeated that "the
HIPAA privacy law" prevented her from telling me anything. I guess
that's the official-sounding evasive reply the lawyers ordered them to
give when confronted with any such questions. In light of the Vioxx
scandal, I'm rather cynical about anything concerning pharmaceutical
corporations.

But she was able to admit that the needles on the prefilled syringes are
different from the screw-on "Precision Glide" needles on the old
version, and the injection may not be as comfortable. That's good to
know.

Has anyone else noticed stinging or other unpleasant or unexpected
differences with the new formulation?

Thanks,

Ted

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DiWitt - 17 Dec 2004 11:56 GMT
I haven't tried the pre-filled as I had just received a 3 month supply of
the old type when they came out.  Are the pre-filled all the 50mg single
dose?  I finally went back to the two shots a week after a month of one 50mg
shot a week. During that month not only did I have flu like symptoms the day
of the injection but my joints just went crazy! When I saw my rheumy this
week she said she's never seen my ankles so bad. They were so swollen I
could barely wear a shoe and she was considering injecting one of them. She
wanted me to have an xray first and make sure I didn't have a stress
fracture. Two days later I woke up and all the swelling was gone. I
attribute the difference to going back on the two shot a week schedule and
it was the day after my third shot which was exactly when I had my original
good response to Enbrel -- after the third injection.  So my joints have
settled down and my foot is NOT fractured. This is good.  I think I'll stay
with the old system.

I sure hope they continue to make it like it is now. It took them forever
to get the good needles. Is there a way to change out the needle on the
prefilled syringes?

Do you think it stings because of the amount in the injection or maybe there
is a preservative in it?

Signature

Cyberhugs,
DianeW

It is only with the heart that one can see rightly; what is essential
is invisible to the eye. --Antoine de Saint Exup?ry

Hello all....

I have been on Enbrel (for psoriatic arthritis) since April. While it
hasn't been the miracle Amgen's advertising agency portrays, it has been
quite helpful. After some rather persistent pushing from Amgen (two
e-mails, a snail mail, and a phone call) I asked my doctor for a
prescription for the new prefilled syringe version.

I took my first injection of the new prefilled syringe version tonight.
The first thing I noticed was that the needle did not go into my skin as
easily or smoothly as with the old version. Then, as I pushed the
plunger down, I felt stinging as the fluid went in. Nothing horrible,
just very unexpected. In the seven months I've been taking the old
version I never felt much of anything during the injection.

I called the Amgen support number to talk to a nurse about this. Maybe I
had a bad lot? She seemed rather evasive when I mentioned the unexpected
stinging, suggesting only that I talk to my doctor about it. When I
asked whether she was aware of other people reporting it, her reply was
that "the HIPAA privacy law" prevented any disclosure of what other
people might have reported. When I said that I didn't understand what
HIPAA had to do with my question (it controls the handling and
disclosure of *individual* medical records), she just repeated that "the
HIPAA privacy law" prevented her from telling me anything. I guess
that's the official-sounding evasive reply the lawyers ordered them to
give when confronted with any such questions. In light of the Vioxx
scandal, I'm rather cynical about anything concerning pharmaceutical
corporations.

But she was able to admit that the needles on the prefilled syringes are
different from the screw-on "Precision Glide" needles on the old
version, and the injection may not be as comfortable. That's good to
know.

Has anyone else noticed stinging or other unpleasant or unexpected
differences with the new formulation?

Thanks,

Ted

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Kelly Cobb - 17 Dec 2004 14:45 GMT
Hi Ted, I'm guessing there's a preservative in the mix with the 50 mg
syringe. I just saw my rheumy last week and he asked if I'd like to try the
new syringe since I've been using the 50 mg dosing for about a year. I
declined because I just wasn't sure that I wouldn't want to go back to the
twice a week system and because I didn't trust Amgen to use good needles. I
didn't even consider the preservative they would have to use.

I hope this is something you can resolve for yourself. maybe your pharmacy
would consider calling the Dr. and requesting a change back to the 25 mg
dosing for you.

Kelly C.;o)
Nann Bell - 17 Dec 2004 14:51 GMT
> Has anyone else noticed stinging or other unpleasant or unexpected
> differences with the new formulation?

I can't say off-hand if I've heard anyone else say this specifically about
the Enbrel.  I am interested though, as I think I'll be going on it soon.  I
know some folks have had stinging from the preservatives in other biologics,
esp. Kineret.  I wonder if the pre-mixed, single dose Enbrel has a
preservative that is not in the other form and perhaprs you are reacting to
that?

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Charlie - 17 Dec 2004 22:15 GMT
I'd be interested in knowing if the needles that come with the 50mg
pre-loaded syringes can be changed.  I've always used a 30 gauge needle of
the same manufacturer rather than the 27 gauge that comes with the Enbrel
pak because of the bruising I get with the 27g.

>> Has anyone else noticed stinging or other unpleasant or unexpected
>> differences with the new formulation?
[quoted text clipped - 8 lines]
> to
> that?
Janet R - 17 Dec 2004 23:08 GMT
Ya'll get 27 and 30 gauge!?  I have to use a 23g for my MTX....

***note to self...talk to RD...ask why such big needle?***

Janet R

| I'd be interested in knowing if the needles that come with the 50mg
| pre-loaded syringes can be changed.  I've always used a 30 gauge needle of
| the same manufacturer rather than the 27 gauge that comes with the Enbrel
| pak because of the bruising I get with the 27g.
Joan Carter - 18 Dec 2004 03:00 GMT
>Ya'll get 27 and 30 gauge!?  I have to use a 23g for my MTX....
>
>***note to self...talk to RD...ask why such big needle?***

That's a large needle for a sub-cu injection. Why ask the RD? Just buy some
smaller ones at the drugstore. Probably the RD doesn't know what size, or care.
Doctors don't generally give many injections. At one time a 25 gauge was used
for sub-cu injections, even those are not used now except for some I.M.s .
---
Joan
Janet R - 18 Dec 2004 03:47 GMT
Oh...I do I.M's....that must make a difference.

Janet R

| >Ya'll get 27 and 30 gauge!?  I have to use a 23g for my MTX....
| >
[quoted text clipped - 6 lines]
| ---
| Joan
Joan Carter - 18 Dec 2004 03:03 GMT
Just read Charlie's original note. The pre-filled syringes come with a 23 gauge
needle? Is Enbrel given sub-cutaneously or intramuscularly? If the latter that
would be why the 23 needle. If sub-cutaneous and the needle can be removed, talk
to your friendly pharmacist about a smaller needle. They are relatively
inexpensive.
---
Joan
Ted - 18 Dec 2004 01:16 GMT
> I'd be interested in knowing if the needles that come with the 50mg
> pre-loaded syringes can be changed.  I've always used a 30 gauge
> needle of the same manufacturer rather than the 27 gauge that comes
> with the Enbrel pak because of the bruising I get with the 27g.

The needle is molded (if that's the word) into the glass at the end of
the prefilled syringe, so there's no way to change it. The new syringe
is about half the diameter of the old one and the label covers it
completely making it more difficult to see when you've injected the
entire dose. And this new dosage form is supposed to be a revolutionary
improvement, if you believe Amgen's marketeers.

I always got quite a bit of bruising from the 25mg kit needle, even
though the injection itself was painless. The bruise lasts up to a week.
But my doctor assured me that it's all normal. Oddly enough, there's no
sign of bruising or soreness after last night's 50mg injection.

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Charlie - 18 Dec 2004 02:26 GMT
I guess one could always simply dump the 50mg into a sterilized vial that
would hold that quantity, purchase 30 gauge syringes at the pharmacy, draw
it out of the vial and inject it with that 30 gauge needle.  Sounds like
something I'd do if Amgen, in its infinite wisdom, discontinues the 25mg
packs:)

On Fri, 17 Dec 2004 14:15:14 -0800, Charlie wrote:

> I'd be interested in knowing if the needles that come with the 50mg
> pre-loaded syringes can be changed.  I've always used a 30 gauge
> needle of the same manufacturer rather than the 27 gauge that comes
> with the Enbrel pak because of the bruising I get with the 27g.

The needle is molded (if that's the word) into the glass at the end of
the prefilled syringe, so there's no way to change it. The new syringe
is about half the diameter of the old one and the label covers it
completely making it more difficult to see when you've injected the
entire dose. And this new dosage form is supposed to be a revolutionary
improvement, if you believe Amgen's marketeers.

I always got quite a bit of bruising from the 25mg kit needle, even
though the injection itself was painless. The bruise lasts up to a week.
But my doctor assured me that it's all normal. Oddly enough, there's no
sign of bruising or soreness after last night's 50mg injection.

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Harvey R. Stone - 18 Dec 2004 13:09 GMT
>I guess one could always simply dump the 50mg into a sterilized vial that
>would hold that quantity, purchase 30 gauge syringes at the pharmacy, draw
>it out of the vial and inject it with that 30 gauge needle.  Sounds like
>something I'd do if Amgen, in its infinite wisdom, discontinues the 25mg
>packs:)

Charlie, Ted,,,   The reason for the large needle is that Enbrel is a
protein and can be bruised.  It is reason it is swirled and not shaken to
mix.
Hhhhm sound like James Bond would say that. LOLOL
Harv

> On Fri, 17 Dec 2004 14:15:14 -0800, Charlie wrote:
>>
[quoted text clipped - 19 lines]
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>  Travel, scenic, and fine art photography
Charlie - 18 Dec 2004 15:33 GMT
I would offer the idea that rheumatolists would not agree with you.

>>I guess one could always simply dump the 50mg into a sterilized vial that
>>would hold that quantity, purchase 30 gauge syringes at the pharmacy, draw
[quoted text clipped - 31 lines]
>> Visit my Virtual Light Table: http://www.tedsimages.com
>>  Travel, scenic, and fine art photography
Harvey R. Stone - 18 Dec 2004 20:43 GMT
>I would offer the idea that rheumatolists would not agree with you.

I want you to ask your RD why  Enbrel is swirled when mixing.   Pushing it
through a needle that is too small could do the same thing.   It reduces the
effectiveness of the shot.

I took Enbrel for almost 3 years and many other people here have taken it
even longer.  If you ask real nice maybe some of them will tell you the same
thing I said.
Harv

>>>I guess one could always simply dump the 50mg into a sterilized vial that
>>>would hold that quantity, purchase 30 gauge syringes at the pharmacy,
[quoted text clipped - 7 lines]
>> Hhhhm sound like James Bond would say that. LOLOL
>> Harv
Charlie - 19 Dec 2004 00:18 GMT
Harv, no offense meant, but if you check with an RD, you might be surprised
to find out that you are incorrect in believing you might hurt some little
molecules by pushing mixed Enbrel solution through a smaller than provided
needle.  I know people who have used 29 and 30 gauge for years and years
with twice-weekly Enbrel shots.  I don't believe there is any science behind
your reasoning -- just your opinion.  But I could be wrong.   Anyone --
please speak up if you have documentation that supports what Harv is saying.
I'm referring to written documentation.  Please don't tell me what an Enbrel
nurse told you; they hardly know what is going on.

>>I would offer the idea that rheumatolists would not agree with you.
>
[quoted text clipped - 18 lines]
>>> Hhhhm sound like James Bond would say that. LOLOL
>>> Harv
Harvey R. Stone - 19 Dec 2004 04:01 GMT
> Harv, no offense meant, but if you check with an RD, you might be
> surprised
[quoted text clipped - 9 lines]
> Enbrel
> nurse told you; they hardly know what is going on.

Would you accept what your own RD tells you and all the training stuff when
you first started?
Thats what really counts.  I see your point.
Harv
Bruce - 19 Dec 2004 22:37 GMT
If you are in fact in the muscle, it is unlikely you will do any damage.
With a smaller gauge needle the only thing that might change is some
stinging if the drug itself is a heavier solution.
Bruce

> Harv, no offense meant, but if you check with an RD, you might be
> surprised
[quoted text clipped - 32 lines]
>>>> Hhhhm sound like James Bond would say that. LOLOL
>>>> Harv
ShenMei9 - 19 Dec 2004 23:10 GMT
My RD basically told me the same thing-swirl, don't shake.  Proteins can be
easily damaged.  I can't imagine that a study needs to be done-it is a simple
question and s simple response: if you shake the protein molecule, does it
retain the same molecular integrity?  Have no idea if putting enbrel through a
smaller needle qualifies, but shaking for sure does.

Anyone want to try to contact Dr.Doc or Susan?

m
Charlie - 20 Dec 2004 01:34 GMT
Sorry, but I don't think I was addressing swirling or shaking.  The topic
was using a needle to inject Enbrel with a gauge smaller than the 27 gauge
that comes with the kit.  I have yet to see any written documentation that
even suggests that using a smaller gauge needle has any affect on the Enbrel
molecules.  Amgen may suggest using 27 gauge, but they don't tell you in the
documentation the reason for so doing.  My suspicion is that it has to do
with their liability if a smaller gauge (thinner) needle should break during
the injection process.

> My RD basically told me the same thing-swirl, don't shake.  Proteins can
> be
[quoted text clipped - 8 lines]
>
> m
ShenMei9 - 20 Dec 2004 01:44 GMT
Didn't think we had entered the arena of a pissing contest yet, charlie.
Thought we were still just throwing out ideas-Oh, I have an idea-if you are
just lookig for info, take what you like and leave the rest behind.  If you
need to be right or enjoy conforntation, let me know so I can killfile you
right away.  I'm getting too old to enjoy these little matches-

m
Charlie - 20 Dec 2004 04:24 GMT
Some can discuss issues; others don't seen able to do so.  This is an
important issue for me and may also be for others.  Perhaps other users or
professionals could add knowledge in this area.

> Didn't think we had entered the arena of a pissing contest yet, charlie.
> Thought we were still just throwing out ideas-Oh, I have an idea-if you
[quoted text clipped - 5 lines]
>
> m
Athena - 20 Dec 2004 05:04 GMT
I don't know if I'm off the subject or not, but here goes.

I find that there are sometimes stubborn bubbles that stick to the the
bottom of the syringe.  It always scares me to see bubbles.

Also, I inject at an angle, withdraw some to see if there is any blood,
but invariably after injection and withdrawal of needle there is some
blood.

Am I totally inept at this or do you guys have similar experiences.
Thanks
Elizabeth
Kelly - 20 Dec 2004 15:54 GMT
Not off subject - nothing is here.

Both the nurse and the doctor told me not to worry about the bubbles (you
mean the small ones not huge big ones I imagine.  I very gently tap the
bottom (very gently) but then inject.

I have been taught to inject straight in - not at an angle. I do so quickly
and don't withdraw.  There is quite often a drop of blood after injecting.
Sometimes it needs a spot bandaid - often just a wipe with a cottonball.
Since my doctor gets these with almost every injection he gives me I have to
assume it is not a problem.  It is not much- and after all you are breaking
the skin.

You aren't inept in my opinion.  Is it working for you?

Kelly

> I don't know if I'm off the subject or not, but here goes.
>
[quoted text clipped - 8 lines]
> Thanks
> Elizabeth
Nann Bell - 20 Dec 2004 22:18 GMT
The spot of blood used to always happen with my allergy injections too.  It
can happen anytime you break the skin.  A drop isn't anything.  A flow of
blood as may happen after your labs are drawn would be an indication of
nicking a vein.

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Simply the thing I am shall make me live --- William Shakespeare

> Not off subject - nothing is here.
>
[quoted text clipped - 25 lines]
>> Thanks
>> Elizabeth
Joan Carter - 20 Dec 2004 16:27 GMT
>I find that there are sometimes stubborn bubbles that stick to the the
>bottom of the syringe.  It always scares me to see bubbles.

Tiny bubbles are not a problem. There are almost invariably some. You need a
really big air bubble to cause problems.

>Also, I inject at an angle, withdraw some to see if there is any blood,
>but invariably after injection and withdrawal of needle there is some
>blood.
>
>Am I totally inept at this or do you guys have similar experiences.

A little blood is not uncommon if you nick a capillary on the way in or out.
---
Joan
Mary Z - 21 Dec 2004 15:28 GMT
>I find that there are sometimes stubborn bubbles that stick to the the
>bottom of the syringe.  It always scares me to see bubbles.

Don't worry about the bubbles it is myth that it can cause an air
embolism.  When I get my Remicade infusion you should see the size of
the air bubbles that go directly in my vein.  Enbrel is sub-cue and
the bubbles are miniscule compared to Remicade.  I asked about it and
the Nurses said tis a myth it would take a large volume of air to
cause a problem.  -- MZ

Visit my website:
http://www.mzuschlag.com
ShenMei9 - 20 Dec 2004 05:04 GMT
I personally find that post quite condescending.  Your original reply to Harv
seemed equally condescending

<<Anyone --
please speak up if you have documentation that supports what Harv is saying.
I'm referring to written documentation. Please don't tell me what an Enbrel
nurse told you; they hardly know what is going on.>>

I'm sure those uneducated enbrel nurses also would find it quite condescending.

You don't get to come into a thread and start demanding the kind of info that
you find acceptable.  There is a rhythm to this group and it usually goes
something like this:

Someone raises an issue or asks
for ideas; people respond, some with medical journal articles, some with
anecdotal, subjective experience, some with unscientific theories; we kick it
all around for a while; sometimes we head off to medscape or web MD or in my
case LWW.com which I find to be easiest access for comprehensive info, or I ask
my boyfriend or ex boyfriend (one works with DWB, the other is on staff at
NIH); sometimes we reach out to Dr. Doc or Dr. Susan Hochs (my suggestion in my
first post).  It's a nice little rhythm and keeps info flowing well.  We also
take little twists in the road usually coming back on course (the whirled not
shaken twist).  It is a lot like medical school or at least the classes I've
taught.

Harv's idea could be wrong-we will get there if it is.  My problem with your
post is the gauntlet-like tone and the "only post if your documentation meets
my standards"

By the way, prefilled for me has not been at all problematic so far.  Not
sting, no bruising, no site reaction.

melinda
DiWitt - 18 Dec 2004 23:21 GMT
I'd be afraid of effecting the med with all that jossling back and forth.

Signature

Cyberhugs,
DianeW

It is only with the heart that one can see rightly; what is essential
is invisible to the eye. --Antoine de Saint Exup?ry

>I guess one could always simply dump the 50mg into a sterilized vial that
>would hold that quantity, purchase 30 gauge syringes at the pharmacy, draw
[quoted text clipped - 25 lines]
> Visit my Virtual Light Table: http://www.tedsimages.com
>  Travel, scenic, and fine art photography
Lee Thompson-Herbert - 19 Dec 2004 08:41 GMT
>I guess one could always simply dump the 50mg into a sterilized vial that
>would hold that quantity, purchase 30 gauge syringes at the pharmacy, draw
>it out of the vial and inject it with that 30 gauge needle.  Sounds like
>something I'd do if Amgen, in its infinite wisdom, discontinues the 25mg
>packs:)

Actually, when I was having problems with the old Enbrel fixed needles,
the injection nurse had me use this method:
I'd mix the injection using the provided syringe (you can skip this part
because it's premixed now)
Get a new, empty BD syringe and unscrew the needle from the end.
Pull the plunger back.
Insert the needle from the filled syringe into the open end of the empty
syringe.
Squirt the Enbrel into your empty sryinge.
Put the needle back on the new syringe.
Do your injection.

Amgen insists that you use no smaller than a 27ga needle because the
protein can be damaged passing through smaller needles.  It can also
be damaged if shaken, or frozen.  Since the stuff is so hideously expensive
it makes sense to take their recommendations to heart.

I'm using Humira now, but I was on Enbrel for almost a year and a half.
When I first started taking it, it still came with a glass syringe with a
fixed needle instead of the BD luer-lok syringe and needles they use now.
Sounds like they've gone back to the fixed-needle syringes, which sucked.
Humira uses a similar syringe and I'm considering going back to loading the
stuff into a luer-lok syringe to avoid the nasty bruising.

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Joan Carter - 18 Dec 2004 03:05 GMT
>The needle is molded (if that's the word) into the glass at the end of
>the prefilled syringe, so there's no way to change it.

That explains it, now if I had read ahead. Please disregard my two posts about
this subject. :-)

---
Joan
Jayne - 22 Dec 2004 22:25 GMT
In case anyone from the UK is reading, I had a 6 month monitoring
appointment (they do it over here to make sure you are still doing well on
the Enbrel and are cost effective!), and asked about these once a week
injections.

They are on their way over to us to, but they are not sure how long it will
be before we get them.

Just in case anyone was reading and wondering.

Jayne

Hello all....

I have been on Enbrel (for psoriatic arthritis) since April. While it
hasn't been the miracle Amgen's advertising agency portrays, it has been
quite helpful. After some rather persistent pushing from Amgen (two
e-mails, a snail mail, and a phone call) I asked my doctor for a
prescription for the new prefilled syringe version.

I took my first injection of the new prefilled syringe version tonight.
The first thing I noticed was that the needle did not go into my skin as
easily or smoothly as with the old version. Then, as I pushed the
plunger down, I felt stinging as the fluid went in. Nothing horrible,
just very unexpected. In the seven months I've been taking the old
version I never felt much of anything during the injection.

I called the Amgen support number to talk to a nurse about this. Maybe I
had a bad lot? She seemed rather evasive when I mentioned the unexpected
stinging, suggesting only that I talk to my doctor about it. When I
asked whether she was aware of other people reporting it, her reply was
that "the HIPAA privacy law" prevented any disclosure of what other
people might have reported. When I said that I didn't understand what
HIPAA had to do with my question (it controls the handling and
disclosure of *individual* medical records), she just repeated that "the
HIPAA privacy law" prevented her from telling me anything. I guess
that's the official-sounding evasive reply the lawyers ordered them to
give when confronted with any such questions. In light of the Vioxx
scandal, I'm rather cynical about anything concerning pharmaceutical
corporations.

But she was able to admit that the needles on the prefilled syringes are
different from the screw-on "Precision Glide" needles on the old
version, and the injection may not be as comfortable. That's good to
know.

Has anyone else noticed stinging or other unpleasant or unexpected
differences with the new formulation?

Thanks,

Ted

---
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